ポリカルボフィル 化学特性,用途語,生産方法
化学的特性
Polycarbophil occurs as fluffy, white to off-white, mildly acidic
polymer powder with slightly acetic odor.
使用
Benzodiazepine anxiolytic
調製方法
Polycarbophils are synthetic, high-molecular-weight, crosslinked
polymers of acrylic acid. These poly(acrylic acid) polymers are
crosslinked with divinyl glycol. They are synthesized via precipitation
polymerization in ethyl acetate and then dried.
安全性
Polycarbophil polymers have a long history of safe and effective use
in topical gels, creams, lotions, and ointments. They have been
shown to have extremely low irritancy properties and are
nonsensitizing with repeated usage.
The use of these polymers is supported by extensive toxicological
studies.
(guinea pig, oral): 2.0 g/kg
(mouse, IP): 0.039 g/kg
(mouse, IV): 0.070 g/kg
(mouse, oral): 4.6 g/kg
(rat, oral): >2.5 g/kg
(rabbit, skin): >3.0 g/kg
Chronic oral toxicity No significant effects in rats or dogs were
observed after being fed with resin as 5% of the diet for 6?
months.
貯蔵
Polycarbophil polymers are stable, hygroscopic materials. They do
not undergo hydrolysis or oxidation under normal conditions. Heat
aging at temperatures below 104°C for up to 2 hours does not affect
the efficiency of the dry polymer. However, prolonged exposure to
excessive temperatures can result in discoloration, reduced stability,
and in some cases plasticization of the polymer. Complete
decomposition occurs with heating for 30 minutes at 260°C.
Polycarbophil polymers do not support bacteria, mold, or fungal
growth in dry powder form. Microbial growth may occur in
mucilages of the polymer solution. Although the gel properties are
not affected by such growth, this phenomenon is usually
unacceptable. The addition of appropriate preservatives prevents
mold and bacterial growth in these mucilages. Mucilages and
emulsions containing these polymers are stable under freeze–thaw
conditions but exposure to high temperatures results in a drop in
viscosity.
Polycarbophil polymers are very hygroscopic and should be
packed in airtight, corrosion-resistant containers. They should be
stored in a cool, dry place, and the container should be kept closed
when not in use. Moisture pickup does not affect the efficiency of
the resins, but resin containing high levels of moisture is more
difficult to disperse and weigh accurately. Glass, plastic, or resinlined
containers are recommended for products containing polycarbophil.
Packaging in aluminum tubes usually requires formulations
to have a pH less than 6.5, and packaging in other metallic
tubes or containers necessitates a pH greater than 7.7 to prolong
polycarbophil stability.
不和合性
Heat may be generated if polycarbophil comes into contact with
strong basic materials such as ammonia, sodium hydroxide,
potassium hydroxide, or strongly basic amines. Polycarbophil
polymers are not compatible with cationic polymers, strong acids,
and high levels of electrolytes, as electrolytes tend to reduce the
viscosity of polycarbophil-based gels.
規制状況(Regulatory Status)
GRAS listed. Included in the FDA Inactive Ingredients Database
(buccal (tablet) and ophthalmic (solution) preparations; topical
patches; vaginal gel). Included in nonparenteral medicines licensed
in the UK.
ポリカルボフィル 上流と下流の製品情報
原材料
準備製品